Regulatory Operations Associate (Entry-Level/Contractor)

Summit Therapeutics Plc-posted 8 months ago

$20 - $25/Yr

Part-time • Entry Level

Miami, FL

Ambulatory Health Care Services

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The Regulatory Operations Associate (Entry-Level/Contractor, part-time) will support the Regulatory Operations team and be responsible for preparation and submission of regulatory submissions (IND safety reports [FDA MedWatch] to FDA), ensuring compliance, and supporting the company's regulatory operations team. Expected hours per week will range from 25-35 hours, 6-8-month contract. Work hours are flexible given that deadlines are met, including completion of critical projects that could require turn around within one day. This is an entry level position, and basic training on electronic submission management and regulatory content management system, drafting standard cover letters and forms, formatting (Word and PDF) will be provided.

Prepare, publish, and submit IND safety reports to the FDA in compliance with regulatory requirements.
Utilize electronic submission management and regulatory content management systems, e.g., Lorenz DocuBridge, to compile, publish, and manage regulatory documents.
Draft standard cover letters for submission packages, adhering to company and regulatory formatting guidelines.
Perform document formatting in both Word and PDF, ensuring accuracy, consistency, and professional presentation.
Conduct quality control (QC) checks to ensure accuracy, compliance, and technical validation.
Collaborate with cross-functional teams to ensure timely and accurate submission of regulatory documents.
Maintain and organize regulatory submission documents in SharePoint and other document management systems.

Bachelor's degree in a life science (biology, chemistry, microbiology, etc.) is required.
Careful attention to detail, a keen eye for data checking, consistency, formatting, style, etc., for document preparation, and organizational skills.
Proficiency in Microsoft Word Office Suite (Word, PowerPoint, and Excel) and Adobe PDF tools for document formatting.
Effective communication and interpersonal skills, with experience working both independently and collaboratively in remote setting.
Must be able to effectively manage time-sensitive and highly confidential documents with accuracy and consistency.
Currently authorized to work in the United States without sponsorship.

Flexible work hours
Part-time contract position

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